11/30/2022 0 Comments Kite pharma![]() And it’s offered some significant responses for a number of patients with advanced cases of blood cancer. Kite - led by CEO Arie Belldegrun - and Novartis are racing to be right at the forefront of introducing personalized cell therapies that reengineer patients’ immune cells to target cancer. That’s up from 41% and 36% reported in February. At a median follow up of 8.7 m, 44% of pts were in response and 39% were in CR. The ORR in the mITT analysis set of 101 pts was 82% (CR 54%, PR 28%), and was consistent across key covariates including disease subtype, refractory status, stage, and IPI score. And the numbers had improved with more patients to report on: On Friday, Kite also updated its data at AACR in an oral plenary presentation. Bigger drops were also recorded for primary mediastinal B-cell lymphoma (PMBCL) and transformed follicular lymphoma (TFL) enrolled in Cohort 2, but the six-month numbers posted were all clearly statistically significant, which helped quiet some dogged criticism of the drug’s ability to provide a durable response. Kite was held up a few months by the need to complete 6-month data on axicabtagene ciloleucel, a goal it accomplished a month ago.Īt six months, the ORR in diffuse large B-cell lymphoma (DLBCL) hit 36%, down only three points from month three. Kite filed the BLA for axicabtagene ciloleucel (KTE-C19, designated as a breakthrough therapy by the FDA) as a treatment for patients with relapsed or refractory aggressive non-Hodgkin lymphoma who are ineligible for autologous stem cell transplant. The question now is whether the FDA will give the Kite’s application a priority review as well, perhaps lining up back-to-back advisory committee meetings to examine the pros and cons of this new wave of cancer therapy. The move puts Kite one step behind Novartis $NVS, which two days ago announced that it had the FDA’s commitment for a speedy review of its own CAR-T. We are greatly impressed with the Kite team and what they have accomplished, and share their belief that cell therapy will be the cornerstone of treating cancer".With the clock ticking down the final hours of Q1, Kite Pharmaceuticals $KITE has kept its pledge to file an application for its pioneering CAR-T therapy in the first quarter. ![]() “The field of cell therapy has advanced very quickly, to the point where the science and technology have opened a clear path toward a potential cure for patients. "The acquisition of Kite establishes Gilead as a leader in cellular therapy and provides a foundation from which to drive continued innovation for people with advanced cancers,” said Gilead CEO John F. 29, 2017 and European approval anticipated in 2018. It currently has one product under review with the FDA–Axi-cel, the company’s lead product, with a U.S. ![]() While the company is focusing on specific types of blood cancer for now, it hopes the treatment can be expended in the future. Kite's CAR-T therapy was developed in collaboration with Zelig Eshhar, a leading pioneer in CAR T cell research and Chair of Immunology Research within the Tel Aviv Sourasky Medical Center, who is also on the company's scientific board. It is currently a very 'in' field, and Kate Pharma is one of its leaders". Steven Tepper, senior Pharma analyst for IBI Investment House Ltd., told Calcalist "all the big pharma companies are trying to get into the cancer treatment market. Food and Drug Administration, among them Basel-based Novartis International AG and Seattle-based Juno Therapeutics. It's a technique quite different from most drugs available in the market today, which are mass produced rather than specialized, but it may just be the breakthrough cancer patients are looking for, and Kite has rivals in the race for approval by the U.S. It is a clinical-stage company specializing in cell-therapy cancer treatments, which engineer the patient's own immune cells to fight cancer, a technology called chimeric antigen receptor T-cell therapy, or CAR-T. Now the company is looking to diversify its revenues and enter the cancer treatment market by buying Kite.īased in Santa Monica, California, Kite was founded by Israeli-American Arie Belldegrun, previously a director of Teva Pharmaceutical Industries Ltd. The drugs made Gilead almost $20 billion in 2015, but a drop in patients and competition in the market saw that revenue fall dramatically year-over-year, while at the same leaving Gilead sitting on a cash pile of almost $36 billion. ![]()
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